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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker GmbH

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  Class 2 Device Recall Stryker GmbH see related information
Date Initiated by Firm June 27, 2018
Create Date August 22, 2018
Recall Status1 Terminated 3 on April 13, 2020
Recall Number Z-2884-2018
Recall Event ID 80613
510(K)Number K051590  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S
T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S
T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S
T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S
T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S
T2 Ankle Arthrd Nail lft 1818-1115S
Code Information Item Number Lot Number:  1819-1020S K0ACFED; 1819-1220S K0CAEC4;  1832-2824S K0BF6C6;  1832-2828S K0CC742;  1832-3826S K0BF6D2;  1818-1115S K0B906C
Recalling Firm/
Manufacturer		 Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Amina Crawford
201-831-5272
Manufacturer Reason
for Recall		 Incomplete seal on the Tyvek lid may compromise the sterility of the device
FDA Determined
Cause 2		 Packaging process control
Action Stryker notified consignee via UPS (with return receipt) on June 27, 2018 advising user of the problem, quarantine product and return. Complete and sign the Recall Notification Business Reply Form. Contact (201) 831-6693.
Quantity in Commerce 38
Distribution US distribution to KY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.
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